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Evaluating Tests for Ciprofloxacin-Resistant Gonorrhea

This study is looking at new tests (Investigational Reflex Test 1, 2, and 3) to see how well they can find a specific genetic change (called gyrA 91F) in Neisseria gonorrhoeae bacteria. This genetic change helps predict if the infection will be resistant to an antibiotic called ciprofloxacin. Researchers want to know if these new tests can accurately identify this genetic change compared to a standard lab method. You could be eligible if you have a positive test for Neisseria gonorrhoeae and enough sample material for testing. The study aims to enroll about 3291 participants.

Study design
This is an observational study, meaning researchers will look at existing samples. It will involve a large number of participants, around 3291, across multiple locations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary results are measured at one day after testing, but the overall follow-up duration for participants is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06815536

Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae

Recruiting
Not specifiedAll AgesObservational
Duke University
~3,291 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Investigational Reflex Test 1Investigational Reflex Test 2Investigational Reflex Test 3

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine
Measured over One day
+8 more outcomes measured

Conditions

Neisseria Gonorrheae Infection

Explore related trials

Gonorrhea

Where it's being run

8 sites across 8 states
California1
Indiana1
Mississippi1
Missouri1
North Carolina1
Utah1
Virginia1
Washington1

Study leadership

  • Michael J. Satlin, MD, MS · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
  • Jeffrey D. Klausner, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Southern California - Los Angeles
  • Vance G. Fowler, MD, MHS · STUDY_DIRECTOR · Duke University

Who to contact

Nyssa Schwager, MSN, RN
[email protected]
708-217-1146
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Be N. gonorrhoeae-positive on an FDA-cleared molecular assay
Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing
Undergo proper handling and storage conditions

Exclusion

The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site
The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source

What this trial measures

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urineOne day

    Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabsOne day

    Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabsOne day

    Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urineOne day

    Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabsOne day

    Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabsOne day

    Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urineOne day

    Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabsOne day

    Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.

  • Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabsOne day

    Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.